Aprepitant in the Management of Biological Therapies-related Severe Pruritus

NCT01683552 | Completed Phase 2

• 1 other identifier: Aprepitant-Itch
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

Conditions

ITCH

Keywords

ITCH

Outcome Measures

Primary Outcomes (1)

• Severity of ITCH

  Patients is asked to grade the intensity of their itch on the VAS, with the strongest possible itch marked at the right end of the line (10) and no itch marked at the left end (0). The VAS score is registered in a diary supplied 7 days before starting the study and every week throughout the study period. Pruritus intensity is evaluated by VAS score once before Aprepitant administration, once 7 days after the first dose of Aprepitant and once a week until the end of biological therapy or the pruritus recurrence. Response (evaluated one week after the first Aprepitant dose) is defined as \> 50% reduction of pruritus intensity compared to the baseline value.

  once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy

Study Arms (2)

Aprepitant

OTHER

Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus

Drug: Aprepitant

Aprepitant after anti-itch standard therapy

OTHER

Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week

Drug: Aprepitant; Drug: Prednisone; Drug: Fexofenadine

Interventions

Aprepitant DRUG

125 mg on day 1; 80 mg on day 3; 80 mg on day 5

Also known as: Emend

Aprepitant; Aprepitant after anti-itch standard therapy

Prednisone DRUG

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),

Aprepitant after anti-itch standard therapy

Fexofenadine DRUG

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)

Aprepitant after anti-itch standard therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed diagnosis of solid tumor
• treatment with anti-EGFR antibodies or TKIs
• first onset of severe pruritus during treatment (≥7 on Visual Analogue Scale (VAS) score)

You may not qualify if:

• oral treatment with antimycotics during 4 weeks preceding enrolment
• topical treatment during the previous 2 weeks
• concomitant,chronic renal or hepatic insufficiency , skin infection or dermatitis.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-Medico of Rome University

Roma, 00128, Italy

Location

Related Publications (1)

• Santini D, Vincenzi B, Guida FM, Imperatori M, Schiavon G, Venditti O, Frezza AM, Berti P, Tonini G. Aprepitant for management of severe pruritus related to biological cancer treatments: a pilot study. Lancet Oncol. 2012 Oct;13(10):1020-4. doi: 10.1016/S1470-2045(12)70373-X. Epub 2012 Sep 18.

  PMID: 22995650 DERIVED

MeSH Terms

Interventions

Aprepitant; Prednisone; fexofenadine

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Daniele Santini, MD, PhD

  Campus Bio-Medico of Rome University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 12, 2012
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

IT (1)